Postoperative IleusPhase 2NCT05001763
Prucalopride for Postoperative Ileus in Patients Undergoing Robot-assisted Laparoscopic Radical Cystectomy
A Phase 2 study testing Prucalopride in people with Postoperative Ileus and Bladder Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial summary
The first purpose is to determine whether prucalopride can promote the recovery of intestinal function after robot-assisted laparoscopic radical cystectomy and urinary diversion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Ileus, Bladder Cancer
- What is being tested?
- Prucalopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Oct 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who are prepared to undergo robot-assisted laparoscopic radical cystectomy + urinary diversion due to bladder tumor;
- urinary diversion: ileal cystectomy or orthotopic neobladder;
- age ≥ 18 years old and ≤ 80 years old;
- ECOG score ≤ 1;
- important laboratory indicators meet:
- Blood routine test: neutrophil count ≥ 1.5 × 109 g / L, leukocyte count ≥ 4.0 × 109 × 10 ~ 9/L, platelet count ≥ 100 × 109 / L, hemoglobin ≥ 9 g /dl
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- Electrolytes: 135mmol/L ≤ serum sodium ≤ 145mmol/L , 2.25mmol/L ≤ serum calcium ≤ 2.75mmol/l, 3.5mmolexL ≤ serum potassium ≤ 5.5mmo/L; Liver function index: glutamic pyruvic transaminase (ALT) and aspartate oxaloacetic transaminase (AST) ≤ 2.5 times the upper limit of normal value (ULN), total bilirubin TBIL ≤ 1.5 × ULN;
- Renal function: serum creatinine ≤ 21. 5 × ULN, eGFR ≥ 30 mL / min; e. Coagulation function: international standardized ratio (INR) < 1.5. f. The left ventricular ejection fraction ((LVEF)) was 50%;
- The drugs that affected the observation of this experiment were not used one week before the selection. Atropine drugs; P-glycoprotein inhibitors: ketoconazole, verapamil, cyclosporine A, quinidine; erythromycin;
- Have good defecation habits, which is defecating more than 3 times a week;
- Have no previous intestinal surgery and no history of other tumors.
- The subjects voluntarily participated, and the subjects themselves must sign an informed consent form (ICF), to show that they understand the purpose and procedures of this study, and are willing to participate in the study. Subjects must be willing and comply with the prohibitions and restrictions set out in the study program.
Who cannot join
- Patients who cannot tolerate radical cystectomy,
- patients with myometrial invasive urothelial carcinoma with distant metastasis (abdominal CT scan + enhancement, chest CT scan, ECT- bone scan, PET-CT, MRI, etc.).
- uncontrollable concomitant diseases, including, but not limited to, persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhoea, or mental illness / social conditions, which will limit compliance with research requirements, significantly increase the risk of AE or impair the patient's ability to write informed consent.
- Patients with the allergy or hypersensitivity of prucalopride;
- Patients with active or symptomatic viral hepatitis or other chronic liver diseases, known to be infected with human immunodeficiency virus (HIV);
- Active pulmonary tuberculosis;
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- Patients with severe heart, liver and kidney diseases;
- Patients with a history of constipation, which is defined as defecation less than 3 times a week, and strenuous defecation.
- Patients with inflammatory bowel disease (ulcerative colitis or Crohn's disease);
- Patients with rare genetic diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption shall not take prucalopride.
- Previous operations involving intestinal, history of other tumors, history of intestinal obstruction;
- Lack of legal capacity or limitation of legal capacity;
- Other situations in which researchers considered it inappropriate to participate in this study.
- Elimination standard
- Those who were treated with other local or systemic that interfere this study at the same time;
- Using other foods and drugs that interfere the tolerance judgment at the same time;
- Violating the requirements of the study scheme, not according to the dose and course of treatment specified in the study plan;
- Poor quality, incomplete and inaccurate of data recording;
- Poor compliance;
- Loss of follow-up.
- Termination criteria
- Subjects require discontinuation of research treatment;
- Deterioration of disease;
- Any clinical AE, laboratory examination abnormalities or concomitant diseases, according to the judgment of the researchers, continuing to participate in the study is not the greatest benefit to the subjects;
- Serious adverse events.
- The informed consent form can no longer be signed freely because of imprisonment or forced detention for the treatment of mental illness or somatic disease (such as infectious diseases);
- Postoperative imagings indicate ileus;
- At the end of treatment, the function of intestines still do not recover.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Clinical Trial of Prucaloprude Succinate in Promoting the Recovery of Intestinal Function After Robot-assisted Laparoscopic Radical Cystectomy and Urinary Diversion
The first purpose is to determine whether prucalopride can promote the recovery of intestinal function after robot-assisted laparoscopic radical cystectomy and urinary diversion.
The secondary objectives is to speed up postoperative ventilation, defecation, reduce the time of first solid food tolerance, reduce postoperative hospital stay, reduce the incidence of readmission due to intestinal obstruction and the incidence of complications within 180 days.
Read the detailed description
The incidence of bladder cancer is getting higher and higher. 30% of them are myometrial invasive bladder cancer, which requires radical cystectomy. This operation is more traumatic, because it involves many physiological structures, and there will be many postoperative complications, of which intestinal complications are the most common. The main manifestation is postoperative ileus (POI).
At present, one is chewing gum after surgery, and the other is the Avimopan, which is recognized as the method to promote intestinal recovery after operation. Avimopan is a peripheral μ-opioid receptor antagonist, which can improve intestinal dysfunction. Because Avimopan has not been widely used in China, its clinical application is limited. It is reported that prucalopride may be one of the methods to promote the recovery of intestinal motility after operation. Prucalopride, an alternative to benzamide, has selective 5-HT4 agonist activity and has previously been shown to significantly improve intestinal motility and transport. The drug was well tolerated and there was no obvious adverse reaction. In addition, prucalopride has been approved in Europe and America for symptomatic treatment of chronic constipation in women whose laxatives do not provide adequate relief. However, its perioperative use in radical cystectomy has not been tested. This study will test the ability and safety of prucalopride to promote the recovery of postoperative intestinal function 2 days before radical cystectomy.
- Conditions
- Postoperative Ileus, Bladder Cancer
- Being tested
- Prucalopride, Placebo
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Resolor
Prucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment
PlaceboDrug
Glucose, 2mg, tablet.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Glucose, 2mg, tablet. Receives: Drug: Placebo |
| Prucalopride | Experimental | Prucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment. Receives: Drug: Prucalopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to defaecation, measured in hours, from the time the surgery ends till the first observed
Measured: up to 30 days after surgery
Secondary outcomes (7)
Postoperative first passing flatus reported by the patients
Measured: up to 30 days after surgery
First solid food tolerance time
Measured: up to 30 days after surgery
Postoperative C-reactive protein(CRP)
Measured: postoperative day 1 and 3
Length of postoperative hospital stay (LOS)(days)
Measured: 30 days or until hospital discharge whichever occurs first
Incidence of readmission within 180 days
Measured: up to 180 days after surgery
Incidence of complications defined according to the Clavien-Dindo Classification within 180 days
Measured: up to 180 days after surgery
Incidence of adverse events related to drug usage
include Diarrhoea, Flatulence, Nausea, Abdominal pain, Headaches, Menstrual disorder, Dizziness, Skeletal pain, ECG nodal arrhythmia
Measured: up to 7 days after drug usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001763
- Sponsor's protocol ID
- IUNU-UC-101
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial of Prucaloprude Succinate in Promoting the Recovery of Intestinal Function After Robot-assisted Laparoscopic Radical Cystectomy and Urinary Diversion
- ClinicalTrials.gov ID
- NCT05001763
- Acronym / sponsor ID
- IUNU-UC-101
- Conditions
- Postoperative Ileus, Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The first purpose is to determine whether prucalopride can promote the recovery of intestinal function after robot-assisted laparoscopic radical cystectomy and urinary diversion.
The secondary objectives is to speed up postoperative ventilation, defecation, reduce the time of first solid food tolerance, reduce postoperative hospital stay, reduce the incidence of readmission due to intestinal obstruction and the incidence of complications within 180 days.
Detailed description
The incidence of bladder cancer is getting higher and higher. 30% of them are myometrial invasive bladder cancer, which requires radical cystectomy. This operation is more traumatic, because it involves many physiological structures, and there will be many postoperative complications, of which intestinal complications are the most common. The main manifestation is postoperative ileus (POI).
At present, one is chewing gum after surgery, and the other is the Avimopan, which is recognized as the method to promote intestinal recovery after operation. Avimopan is a peripheral μ-opioid receptor antagonist, which can improve intestinal dysfunction. Because Avimopan has not been widely used in China, its clinical application is limited. It is reported that prucalopride may be one of the methods to promote the recovery of intestinal motility after operation. Prucalopride, an alternative to benzamide, has selective 5-HT4 agonist activity and has previously been shown to significantly improve intestinal motility and transport. The drug was well tolerated and there was no obvious adverse reaction. In addition, prucalopride has been approved in Europe and America for symptomatic treatment of chronic constipation in women whose laxatives do not provide adequate relief. However, its perioperative use in radical cystectomy has not been tested. This study will test the ability and safety of prucalopride to promote the recovery of postoperative intestinal function 2 days before radical cystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboGlucose, 2mg, tablet. |
| Prucalopride | Experimental | Drug: PrucalopridePrucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- patients who are prepared to undergo robot-assisted laparoscopic radical cystectomy + urinary diversion due to bladder tumor;
- urinary diversion: ileal cystectomy or orthotopic neobladder;
- age ≥ 18 years old and ≤ 80 years old;
- ECOG score ≤ 1;
- important laboratory indicators meet:
Key exclusion criteria (28 listed)
- Patients who cannot tolerate radical cystectomy,
- patients with myometrial invasive urothelial carcinoma with distant metastasis (abdominal CT scan + enhancement, chest CT scan, ECT- bone scan, PET-CT, MRI, etc.).
- uncontrollable concomitant diseases, including, but not limited to, persistent infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhoea, or mental illness / social conditions, which will limit compliance with research requirements, significantly increase the risk of AE or impair the patient's ability to write informed consent.
- Patients with the allergy or hypersensitivity of prucalopride;
- Patients with active or symptomatic viral hepatitis or other chronic liver diseases, known to be infected with human immunodeficiency virus (HIV);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucaloprideAlso: ResolorPrucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment | Drug | Prucalopride |
| PlaceboGlucose, 2mg, tablet. | Drug | Placebo |
Primary outcome
Time to defaecation, measured in hours, from the time the surgery ends till the first observed
Time frame: up to 30 days after surgery
7 secondary outcomes
Postoperative first passing flatus reported by the patients
Time frame: up to 30 days after surgery
First solid food tolerance time
Time frame: up to 30 days after surgery
Postoperative C-reactive protein(CRP)
Time frame: postoperative day 1 and 3
Length of postoperative hospital stay (LOS)(days)
Time frame: 30 days or until hospital discharge whichever occurs first
Incidence of readmission within 180 days
Time frame: up to 180 days after surgery
Incidence of complications defined according to the Clavien-Dindo Classification within 180 days
Time frame: up to 180 days after surgery
Incidence of adverse events related to drug usage
Time frame: up to 7 days after drug usage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prucalopride in people with Postoperative Ileus and Bladder Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongqian Guo, MD (13605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to defaecation, measured in hours, from the time the surgery ends till the first observed (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.